Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06548412 | CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers | PHASE1 | RECRUITING | 50 | — | — | Jan 22, 2025 | May 1, 2029 | Jan 20, 2026 | 1 | United States |
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
| Arm | Type | Description |
|---|---|---|
| Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatin | EXPERIMENTAL | Participants will be administered treatment on an outpatient basis |
| Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatin | EXPERIMENTAL | Participants will be administered treatment on an outpatient basis |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | Given by IV |
| Cisplatin | DRUG | Given by IV |
| Durvalumab | DRUG | Given by IV |
| CTX-009 | DRUG | Given by IV |
Inclusion Criteria: 1. Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CTX-009 in combination with durvalumab, gemcitabine, and cisplatin in patients \<18 years of age, children are excluded from this study. 2. Ability to understand and the willingness ...